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Botulism and Infant Botulism...

PEDIATRICS Vol. 108 No. 5 November 2001, pp. 1062-1071

Botulinum Toxin Type A Neuromuscular Blockade in the Treatment of Equinus Foot Deformity in Cerebral Palsy: A Multicenter, Open-Label Clinical Trial

Received Oct 27, 2000; accepted Apr 23, 2001.

L. Andrew Koman*, Allison BrashearDagger , Samuel Rosenfeld§, Henry Chambersparallel , Barry Russman#, Mercer Rang, Leon Root**, Eugenio FerrariDagger Dagger , J. Garcia de Yebenes Prous§§, Beth P. Smith*, Catherine Turkelparallel , Jennifer M. Walcottparallel , and Patricia T. Molloyparallel

From the * Department of Orthopaedic Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina; Dagger  Indiana University School of Medicine, Indianapolis, Indiana; § Children's Hospital of Orange County, Irvine, California; parallel  Children's Hospital, San Diego, California; # Newington Children's Hospital, Newington, Connecticut;  Hugh MacMillan Rehabilitation Center, Toronto, Canada; ** Hospital for Special Surgery, New York, New York; Dagger Dagger  Clinical Neurologica, Policlinic, Italy; §§ Fundacion Jiminez Diaz, Universidad Autonoma de Madrid, Spain; and || Allergan, Inc, Irvine, California.

Background.  Focal spasticity of the gastrocnemius-soleus muscles causes equinus gait in children with cerebral palsy (CP). Botulinum toxin type A (BTX-A), a neuromuscular blocking agent, reduces muscle tone/overactivity in dystonia, stroke, and CP.

Objective.  A prospective, open-label, multicenter clinical trial evaluated the long-term safety and efficacy of repeated intramuscular injections of BTX-A on equinus gait in CP children.

Methods.  Nine centers enrolled 207 children. BTX-A injections (4 U/Kg) were given approximately every 3 months (maximum dose 200 U per treatment). Outcome measures included a Physician Rating Scale of gait, ankle range of motion measurements, and the incidence and profile of adverse events.

Results.  One hundred fifty-five (75%) of 207 children completed at least 1 year with a total of 302 patient years of BTX-A treatment. The mean duration of BTX-A exposure was 1.46 years per patient. Dynamic gait pattern on the Physician Rating Scale improved in 46% of patients (86/185) at first follow-up. The response was maintained in 41% to 58% of patients for 2 years. Both gait pattern and ankle position improved at every visit. The most common treatment-related adverse events included increased stumbling, leg cramps, leg weakness, and calf atrophy in 1% to 11% of patients. No treatment-related serious adverse events were reported. Only 6% (7/117) of patients with pre- and postantibody samples had both detectable antibodies and a subsequent treatment failure.

Conclusion.  BTX-A proved both safe and effective in the chronic management of focal muscle spasticity in children with equinus gait.  Key words:  BTX-A, cerebral palsy, equinus foot deformity, neuromuscular blockade, pediatric patients, spasticity.




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